Angiography and Electrogram Guided Bachmann Bundle Pacing ((ANGEL-BBP))

Pugazhendhi Vijayaraman

Status: Enrolling

Conditions: Heart Diseases

Treatments: Diagnostic Test: Angiography only; Diagnostic Test: Angiography and ECG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07110922

2025-0403

Details and patient eligibility

About

People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB).

This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle.

Both of these options are FDA approved and used in standard practice.

Full description

The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach.

Eligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.

During implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.

The study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram/ECG only guided BBP patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients > 18 years of age
2. Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
3. Patient is willing to comply with all study procedures and be available for the duration of the study.

Exclusion criteria

1. Inability to provide informed consent
2. Pregnant
3. Enrolled in a concurrent study that may confound the results of this study.
4. Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)
5. Renal dysfunction with serum Creatinine >3.0 mg/dl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Angiography only

Experimental group

Treatment:

Diagnostic Test: Angiography only

Angiography and ECG

Experimental group

Treatment:

Diagnostic Test: Angiography and ECG